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1.  COMPARABLE EFFECTIVENESS OF CAUDAL VS. TRANS-FORAMINAL EPIDURAL STEROID INJECTIONS 
Study Design: Retrospective case-control study.
Objective: To compare the effectiveness between caudal and trans-foraminal epidural steroid injections for the treatment of primary lumbar radiculopathy.
Summary of Background Data: Spinal injections with steroids play an important role in non-operative care of lumbar radiculopathy. The trans-foraminal epidural steroid injection (TESI) theoretically has a higher success rate based on targeted delivery to the symptomatic nerve root. To our knowledge, these results have not been compared with other techniques of epidural steroid injection.
Methods: 93 patients diagnosed with primary lumbar radiculopathy of L4, L5, or SI were recruited for this study: 39 received caudal epidural steroid injections (ESI) and 54 received trans-foraminal epidural steroid injections (TESI). Outcomes scores included the SF-36, Oswestry disability index (ODI) and pain visual analogue scale (VAS), and were recorded at baseline, post-treatment (<6 months), long-term (>1 year). The average follow-up was 2 years, and 16 patients were lost to follow-up. The endpoint “surgical intervention” was a patient-driven decision, and considered failure of treatment. Intent-to-treat analysis, and comparisons included t-test, Chi-square, and Wilcoxon rank-sum test.
Results: Baseline demographics and outcomes scores were comparable for both treatment groups (ESI vs. TESI): (SF-36 PCS (32.3 ± 7.5 vs. 29.5 ± 8.9 respectively; p = 0.173), MCS (41.2 ± 12.7 vs. 41.1 ± 10.9, respectively; p = 0.971), and VAS (7.4 ±2.1 vs. 7.9 ± 1.2, respectively; p = 0.228)). Surgery was indicated for failure of treatment at a similar rate for both groups (41.0% vs. 44.4%, p=0.743). Symptom improvement was comparable between both treatment groups (ESI vs. TESI): SF-36 PCS improved to 42.0±11.8 and 37.7±12.3, respectively; p=0.49; ODI improved from 50.0±21.2 to 15.6±17.9and from 62.1±17.9 to 26.1±20.3, respectively (p=0.407).
Conclusions: The effectiveness of TESI is comparable to that of ESI (approximately 60%) for the treatment of primary lumbar radiculopathy. The increased complexity of TESI is not justified for primary cases, and may have a more specific role in recurrent disease or for diagnostic purposes.
PMCID: PMC2723700  PMID: 19742093
2.  The flow patterns of caudal epidural in upper lumbar spinal pathology 
European Spine Journal  2010;20(5):804-807.
Epidural steroid injections are an important therapeutic modality employed by spinal surgeons in the treatment of patients with chronic low back pain with or without lumbar radiculopathy. The caudal epidural is a commonly used and well-established technique; however, little is known about the segmental level of pathology that may be addressed by this intervention. This prospective study of over 50 patients aimed to examine the spreading pattern of this technique using epidurography. The effect of variation in Trendelenburg tilt and the eradication of lumbar lordosis on the cephalic distribution of the injectate were investigated. 52 patients with low back pain and radiculopathy underwent caudal epidural. All had 20 ml volume injected, comprised of 5 ml contrast (Ultravist™ Schering) 2 ml Triamcinolone (Adcortyl™ Squibb) and 13 ml local anaesthetic (1% lignocaine). Patients were randomised to either 0° or 30° of Trendelenburg tilt, as referenced from the lumbar spine. Patients were further randomised to presence or absence of lumbar lordosis, which was eradicated using a flexion device placed beneath the prone patient. A lateral image of each sacrum was obtained, to identify variations in sacral geometry particularly resistant to cephalic spread of injectate. The highest segment reached on fluoroscopy was recorded post injection. Fifty-two patients with a mean age of 50 years underwent caudal epidural. Thirty-one were in 0° head tilt, with 21 in 30° of head tilt. In each of these groups, 50% had their lumbar lordosis flattened prior to caudal injection. The median segmental level reached was L3, with a range from T9 to L5. Eradication of lumbar lordosis did not significantly alter cephalic spread of injectate. There was a trend for 30° tilt to extend the upper level reached by caudal injection (p = 0.08). There were no adverse events in this series. Caudal epidural is a reliable and relatively safe procedure for the treatment of low back pain. Pathology at L3/4 and L4/5 and L5/S1 can be approached by this technique. Although in selected cases thoracic and high lumbar levels can be reached, this is variable. If pathology at levels above L3 needs to be addressed, we propose a 30° head tilt may improve cephalic drug delivery. The caudal route is best reserved for pathology below L3.
doi:10.1007/s00586-010-1613-5
PMCID: PMC3082677  PMID: 21113636
Caudal epidural; Lumbar spine
3.  Arachnoiditis Following Caudal Epidural Injections for the Lumbo-Sacral Radicular Pain 
Asian Spine Journal  2013;7(4):355-358.
Caudal epidural steroid injection is a very common intervention in treatment of low back pain and sciatica symptoms. Although extensively used, it is not devoid of complications. A few reports of chemical and infective arachnoiditis exist following lumbar epidural anaesthesia, but none following a caudal epidural steroid injection.We report a case of arachnoiditis following caudal epidural steroid injections for lumbar radiculopathy. The patient presented with contralateral sciatica, worsening low back pain and urinary retention few days following the injection, followed by worsening motor functions in L4/L5/S1 myotomes with resultant dense foot drop. Gadolinium-enhanced magnetic resonance imaging suggested infective arachnoiditis with diffuse enhancement and clumping of the nerve roots within the lumbar and sacral thecal sac. As the number of injections in the management of back pain and lumbo-sacral radicular pain is increasing annually, it is imperative to have a thorough understanding of this potentially dangerous complication and educate the patients appropriately.
doi:10.4184/asj.2013.7.4.355
PMCID: PMC3863664  PMID: 24353855
Caudal; Epidural; Low back pain; Sciatica; Arachnoiditis
4.  Fluoroscopic Caudal Epidural Injections in Managing Post Lumbar Surgery Syndrome: Two-Year Results of a Randomized, Double-Blind, Active-Control Trial 
Study Design: A randomized, active control, double-blind trial. Objective: To evaluate the effectiveness of fluoroscopically directed caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to post lumbar surgery syndrome. Summary of Background Data: There is a paucity of evidence concerning caudal epidural injections for managing chronic persistent low back pain with or without lower extremity pain caused by post lumbar surgery syndrome.
Methods: This active control randomized study included 140 patients with 70 patients in each group. Group I received 0.5% lidocaine, 10 mL; Group II received 9 mL of 0.5% lidocaine mixed with 1 mL of 6 mg of nonparticulate betamethasone. The multiple outcome measures included the numeric rating scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as at least 50% improvement in pain and Oswestry Disability Index scores. Patients with a positive response to the first 2 procedures with at least 3 weeks of relief were considered to be successful. All others were considered as failures.
Results: Overall in Group I, 53% and 47% of the patients and in Group II, 59% and 58% of the patients, showed significant improvement with reduction in pain scores and disability index at 12 months and 24 months. In contrast, in the successful groups, significant pain relief and improvement in function were observed in 70% and 62% of Group I at one and 2 years; in 75% and 69% of Group II at one and 2 years. The results in the successful group showed that at the end of the first year patients experienced approximately 38 weeks of relief and at the end of 2 years Group I had 62 weeks and Group II had 68 weeks of relief. Overall total relief for 2 years was 48 weeks in Group I and 54 weeks in Group II. The average procedures in the successful groups were at 4 in one year and 6 at the end of 2 years.
Conclusion: Caudal epidural injections of local anesthetic with or without steroid might be effective in patients with chronic persistent low back and/or lower extremity pain in patients with post lumbar surgery syndrome.
doi:10.7150/ijms.4672
PMCID: PMC3461763  PMID: 23028241
Chronic low back pain; post lumbar surgery syndrome; recurrent disc herniation; epidural fibrosis; spinal stenosis; caudal epidural steroid injections.
5.  Single Shot Epidural Injection for Cervical and Lumbosaccral Radiculopathies: A Preliminary Study 
The Korean Journal of Pain  2010;23(4):254-257.
Background
Epidural steroid injection is an established treatment modality for intervertebral disc prolapse leading to radiculopathy. In cases where two levels of radiculopathy are present, two separate injections are warranted. Herein, we present our experience of management of such cases with a single epidural injection of local anaesthetic, tramadol and methylprednisolone, and table tilt for management of both radiculopathies.
Methods
50 patients of either sex aged between 35-65 years presenting with features of cervical and lumbar radiculopathic pain were included and were subjected to single lumbar epidural injection of local anaesthetic, tramadol and methylprednisolone, in the lateral position. The table was then tilted in the trendelberg position with a tilt of 25 degrees, and patients were maintained for 10 minutes before being turned supine. All patients were administered 3 such injections with an interval of 2 weeks between subsequent injections, and pain relief was assessed with a visual analogue scale. Immediate complications after the block were assessed.
Results
Immediate and post procedural complications observed were nausea and vomiting (20%), painful injection site (4%), hypotension (10%) and high block (4%). Pain relief was assessed after the three injections by three grades: 37 (74%) had complete resolution of symptoms; 18% had partial relief and 8% did not benefit from the procedure.
Conclusions
This technique may be used as an alternative technique for pain relief in patients with unilateral cervical and lumbar radiculopathies.
doi:10.3344/kjp.2010.23.4.254
PMCID: PMC3000622  PMID: 21217889
cervical; epidural; lumbar; radiculopathy; steroid; tramadol
6.  Cephalic spreading levels after volumetric caudal epidural injections in chronic low back pain. 
Journal of Korean Medical Science  2001;16(2):193-197.
The volumetric caudal epidural steroid injection has been advocated to facilitate the delivery of medications to the lesion site. This study was aimed to examine the actual spreading patterns of this technique, using epidurogram. A total of 32 patients with chronic low back pain accompanied by radiculopathy of various causes (degenerative spondylosis, herniated nucleus pulposus, spondylolisthesis, and spinal stenosis) were included. The volumetric caudal epidural injection of the 10 mL mixture of contrast medium 5 mL, 0.5% bupivacaine 1 mL, triamcinolone 1.5 mL (60 mg) and normal saline 25 mL was performed. Immediately after the cessation of the first spread, the subsequent solution of another 10 mL of contrast medium 5 mL, 0.5% bupivacaine 1 mL and normal saline 4 mL was injected. This procedure was repeated serially until the total volume to be 50 mL. Continuous fluoroscopic imaging was obtained after each injection. Average time taken to complete the study was 37 sec per every 10 mL. The spreading levels of the mixture were distributed mainly at mid to lower lumbar area in the majority of the patients. During the subsequent injections, the levels were not changed significantly. This was thought to be due to the minimal resistance in cephalad direction, anatomic variations and Starling effect of epidural space.
PMCID: PMC3054722  PMID: 11306746
7.  Solitary Epidural Lipoma with Ipsilateral Facet Arthritis Causing Lumbar Radiculopathy 
Asian Spine Journal  2012;6(3):203-206.
A 55-year-old obese man (body mass index, 31.6 kg/m2) presented radiating pain and motor weakness in the left leg. Magnetic resonance imaging showed an epidural mass posterior to the L5 vertebral body, which was isosignal to subcutaneous fat and it asymmetrically compressed the left side of the cauda equina and the exiting left L5 nerve root on the axial T1 weighted images. Severe arthritis of the left facet joint and edema of the bone marrow regarding the left pedicle were also found. As far as we know, there have been no reports concerning a solitary epidural lipoma combined with ipsilateral facet arthorsis causing lumbar radiculopathy. Solitary epidural lipoma with ipsilateral facet arthritis causing lumbar radiculopathy was removed after the failure of conservative treatment. After decompression, the neurologic deficit was relieved. At a 2 year follow-up, motor weakness had completely recovered and the patient was satisfied with the result. We recommend that a solitary epidural lipoma causing neurologic deficit should be excised at the time of diagnosis.
doi:10.4184/asj.2012.6.3.203
PMCID: PMC3429612  PMID: 22977701
Solitary epidural lipoma; Posterior facet; Ipsilateral arthritis; Lumbar radiculopathy
8.  Lumbar epidural perineural injection: a new technique 
European Spine Journal  1997;6(5):357-361.
Two controlled studies for a new epidural, perineural, singleshot, selective nerve root injection with a double-needle approach to the anterior epidural space of the lumbar spinal canal are presented. The results were analysed to determine the effectiveness of the new epidural perineural injection technique. The trial comprised two controlled studies on 182 patients. One study compared prospectively randomized results of patients with lumbar radicular syndromes who received epidural perineural injections (n = 47), conventional posterior epidural injections (n = 40) and, as a control group, paravertebral local anaesthetic (n = 46). A second, prospective, double-blind study compared the effect of epidural perineural injections with triamcinolone (n = 24) and pure saline (n = 25). Epidural perineural injections were more effective than conventional posterior epidural injections. Both epidural groups had better results than the paravertebral local injection group. Epidural perineural injections with steroids (10 mg triamcinolone) were more effective than saline alone. A systemic steroid effect was excluded by additional intramuscular steroid injections in the saline group. There were no severe complications or side effects in any of the three groups. The studies concluded that single-shot epidural perineural injection is effective in the treatment of lumbar radicular pain. It is a “one drop only” therapy to the source of pain.
doi:10.1007/BF01142687
PMCID: PMC3454603  PMID: 9391811
Epidural perineural injection; Local injection therapy; Lumbar radicular syndrome; Conservative treatment
9.  Cervical radiculopathy: Study protocol of a randomised clinical trial evaluating the effect of mobilisations and exercises targeting the opening of intervertebral foramen [NCT01500044] 
Background
Cervical radiculopathy is a common form of neck pain and has been shown to lead to severe disability. Clinical rehabilitation approaches for cervical radiculopathies commonly include exercise and manual therapy interventions targeting the opening of intervertebral foramen, but evidence regarding their effectiveness is scarce. The primary objective of this randomised clinical trial is to compare, in terms of pain and disability, a rehabilitation program targeting the opening of intervertebral foramen to a conventional rehabilitation program, for patients presenting acute or subacute cervical radiculopathies. The hypothesis is that the rehabilitation program targeting the opening of intervertebral foramen will be significantly more effective in reducing pain and disability than the conventional rehabilitation program.
Methods/Design
This study is a double-blind (participants and evaluators blinded) randomised clinical trial that will allow the comparison of patients with a cervical radiculopathy randomly assigned to one of two groups: one group will receive a 4-week rehabilitation program targeting the opening of intervertebral foramen, and the second group will receive a 4-week conventional rehabilitation program. Thirty-six subjects with cervical radiculopathy will be recruited from participating medical and physiotherapy clinics and will be evaluated at baseline, at the end of the 4-week program and four weeks following the end of the program. The primary outcome measure will be the validated Neck Disability Index questionnaire. Secondary outcome measures will include the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire, a numerical pain rating scale, cervicothoracic mobility and patients' perceived global rating of change. During the 4-week rehabilitation program, each participant will take part in eight physiotherapy treatment sessions (2 session/week) and will perform a home exercise program. A mixed-model, 2-way ANOVA will be used to analyze the effects of the rehabilitation programs.
Discussion
Control trials are needed to define ideal intervention approaches in rehabilitation for this population. This randomised clinical trial will be the first study that directly compares a rehabilitation program targeting the opening of intervertebral foramen to a conventional rehabilitation program for patients with cervical radiculopathy. The results of this study may help to establish best clinical practice guidelines for this patient population.
Trial Registration
ClinicalTrials.gov: NCT01500044
doi:10.1186/1471-2474-13-10
PMCID: PMC3299659  PMID: 22293092
Cervical; Radiculopathy; Neck pain; Exercises; Mobilisations; Intervertebral foramen
10.  Fluoroscopic caudal epidural injections in managing chronic axial low back pain without disc herniation, radiculitis, or facet joint pain 
Journal of Pain Research  2012;5:381-390.
Background
Chronic low back pain without disc herniation is common. Various modalities of treatments are utilized in managing this condition, including epidural injections. However, there is continued debate on the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections.
Methods
A randomized, double-blind, actively controlled trial was conducted. The objective was to evaluate the ability to assess the effectiveness of caudal epidural injections of local anesthetic with or without steroids for managing chronic low back pain not caused by disc herniation, radiculitis, facet joints, or sacroiliac joints. A total of 120 patients were randomized to two groups; one group did not receive steroids (group 1) and the other group did (group 2). There were 60 patients in each group. The primary outcome measure was at least 50% improvement in Numeric Rating Scale and Oswestry Disability Index. Secondary outcome measures were employment status and opioid intake. These measures were assessed at 3, 6, 12, 18, and 24 months after treatment.
Results
Significant pain relief and functional status improvement (primary outcome) defined as a 50% or more reduction in scores from baseline, were observed in 54% of patients in group 1 and 60% of patients in group 2 at 24 months. In contrast, 84% of patients in group 1 and 73% in group 2 saw significant pain relief and functional status improvement in the successful groups at 24 months.
Conclusion
Caudal epidural injections of local anesthetic with or without steroids are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis.
doi:10.2147/JPR.S35924
PMCID: PMC3474158  PMID: 23091395
chronic axial low back pain; discogenic pain; disc herniation; caudal epidural injections
11.  Study Protocol- Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults 
Background
Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis.
Methods
We will recruit up to 400 patients with lumbar central canal spinal stenosis from at least 9 clinical sites over 2 years. Patients with spinal instability who require surgical fusion, a history of prior lumbar surgery, or prior epidural steroid injection within the past 6 months are excluded. Participants are randomly assigned to receive either ESI with local anesthetic or the control intervention (epidural injections with local anesthetic alone). Subjects receive up to 2 injections prior to the primary endpoint at 6 weeks, at which time they may choose to crossover to the other intervention.
Participants complete validated, standardized measures of pain, functional disability, and health-related quality of life at baseline and at 3 weeks, 6 weeks, and 3, 6, and 12 months after randomization. The primary outcomes are Roland-Morris Disability Questionnaire and a numerical rating scale measure of pain intensity at 6 weeks. In order to better understand their safety, we also measure cortisol, HbA1c, fasting blood glucose, weight, and blood pressure at baseline, and at 3 and 6 weeks post-injection. We also obtain data on resource utilization and costs to assess cost-effectiveness of epidural steroid injection.
Discussion
This study is the first multi-center, double-blind RCT to evaluate the effectiveness of epidural steroid injections in improving pain and function among older adults with lumbar spinal stenosis. The study will also yield data on the safety and cost-effectiveness of this procedure for older adults.
Trial Registration
Clinicaltrials.gov NCT01238536
doi:10.1186/1471-2474-13-48
PMCID: PMC3349603  PMID: 22458343
12.  Comparison of the caudal and lumbar approaches to the epidural space 
Annals of the Rheumatic Diseases  2000;59(11):879-882.
OBJECTIVES—To investigate the accuracy of placement of epidural injections using the lumbar and caudal approaches. To identify which factors, if any, predicted successful placement.
METHODS—200 consecutive patients referred to a pain clinic for an epidural injection of steroid were randomly allocated to one of two groups. Group L had a lumbar approach to the epidural space and group C a caudal approach to the epidural space. Both groups then had epidurography performed using Omnipaque and an image intensifier to determine the position of the needle.
RESULTS—Body mass index (BMI), grade of operator, and route of injection were predictors of a successful placement. 93% of lumbar and 64% of caudal epidural injections were correctly placed (p< 0.001). 97% of lumbar and 85% of caudal epidural injections clinically thought to be correctly placed were confirmed radiographically. For epidural injections where the clinical impression was "maybe", 91% of lumbar injections, but only 45% of caudal injections were correctly placed. Obesity was associated with a reduced chance of successful placement (odds ratio (OR) 0.34 (95% confidence interval (CI) 0.17 to 0.72) BMI >30 v BMI <30). A more senior grade of operator was associated with a reduced chance of successful placement (OR 0.16 (95% CI 0.03 to 0.89) consultant v other). However, small numbers may have accounted for the latter result.
CONCLUSIONS—The weight of the patient and intended approach need to be considered when deciding the method used to enter the epidural space. In the non-obese patient, lumbar epidural injections can be accurately placed without x ray screening, but caudal epidural injections, to be placed accurately, require x ray screening no matter what the weight of the patient.


doi:10.1136/ard.59.11.879
PMCID: PMC1753031  PMID: 11053065
13.  Fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar axial or discogenic pain 
Journal of Pain Research  2012;5:301-311.
Among the multiple causes of chronic low back pain, axial and discogenic pain are common. Various modalities of treatments are utilized in managing discogenic and axial low back pain including epidural injections. However, there is a paucity of evidence regarding the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections. In an interventional pain management practice in the US, a randomized, double-blind, active control trial was conducted. The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of discogenic origin. However, disc herniation, radiculitis, facet joint pain, or sacroiliac joint pain were excluded. Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Primary outcome measures included the pain relief-assessed by numeric rating scale of pain and functional status assessed by the, Oswestry Disability Index, Secondary outcome measurements included employment status, and opioid intake. Significant improvement or success was defined as at least a 50% decrease in pain and disability. Significant improvement was seen in 77% of the patients in Group I and 67% of the patients in Group II. In the successful groups (those with at least 3 weeks of relief with the first two procedures), the improvement was 84% in Group I and 71% in Group II. For those with chronic function-limiting low back pain refractory to conservative management, it is concluded that lumbar interlaminar epidural injections of local anesthetic with or without steroids may be an effective modality for managing chronic axial or discogenic pain. This treatment appears to be effective for those who have had facet joints as well as sacroiliac joints eliminated as the pain source.
doi:10.2147/JPR.S32699
PMCID: PMC3442746  PMID: 23055773
lumbar disc herniation; axial or discogenic pain; lumbar interlaminar epidural injections; local anesthetic; steroids; controlled comparative local anesthetic blocks; NCT00681447
14.  Epidural Lysis of Adhesions 
The Korean Journal of Pain  2013;27(1):3-15.
As our population ages and the rate of spine surgery continues to rise, the use epidural lysis of adhesions (LOA) has emerged as a popular treatment to treat spinal stenosis and failed back surgery syndrome. There is moderate evidence that percutaneous LOA is more effective than conventional ESI for both failed back surgery syndrome, spinal stenosis, and lumbar radiculopathy. For cervical HNP, cervical stenosis and mechanical pain not associated with nerve root involvement, the evidence is anecdotal. The benefits of LOA stem from a combination of factors to include the high volumes administered and the use of hypertonic saline. Hyaluronidase has been shown in most, but not all studies to improve treatment outcomes. Although infrequent, complications are more likely to occur after epidural LOA than after conventional epidural steroid injections.
doi:10.3344/kjp.2014.27.1.3
PMCID: PMC3903797  PMID: 24478895
epidural adhesiolysis; epidural lysis of adhesions; epidural neuroplasty; epiduroscopy; failed back surgery syndrome
15.  Assessment of Effectiveness of Percutaneous Adhesiolysis in Managing Chronic Low Back Pain Secondary to Lumbar Central Spinal Canal Stenosis 
Background: Chronic persistent low back and lower extremity pain secondary to central spinal stenosis is common and disabling. Lumbar surgical interventions with decompression or fusion are most commonly performed to manage severe spinal stenosis. However, epidural injections are also frequently performed in managing central spinal stenosis. After failure of epidural steroid injections, the next sequential step is percutaneous adhesiolysis and hypertonic saline neurolysis with a targeted delivery. The literature on the effectiveness of percutaneous adhesiolysis in managing central spinal stenosis after failure of epidural injections has not been widely studied.
Study Design: A prospective evaluation.
Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States.
Objective: To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain with lumbar central spinal stenosis.
Methods: Seventy patients were recruited. The initial phase of the study was randomized, double-blind with a comparison of percutaneous adhesiolysis with caudal epidural injections. The 25 patients from the adhesiolysis group continued with follow-up, along with 45 additional patients, leading to a total of 70 patients. All patients received percutaneous adhesiolysis and appropriate placement of the Racz catheter, followed by an injection of 5 mL of 2% preservative-free lidocaine with subsequent monitoring in the recovery room. In the recovery room, each patient also received 6 mL of 10% hypertonic sodium chloride solution, and 6 mg of non-particulate betamethasone, followed by an injection of 1 mL of sodium chloride solution and removal of the catheter.
Outcomes Assessment: Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12, 18 and 24 months post treatment. The primary outcome measure was 50% or more improvement in pain scores and ODI scores.
Results: Overall, a primary outcome or significant pain relief and functional status improvement of 50% or more was seen in 71% of patients at the end of 2 years. The overall number of procedures over a period of 2 years were 5.7 ± 2.73.
Limitations: The lack of a control group and a prospective design.
Conclusions: Significant relief and functional status improvement as seen in 71% of the 70 patients with percutaneous adhesiolysis utilizing local anesthetic steroids and hypertonic sodium chloride solution may be an effective management strategy in patients with chronic function limiting low back and lower extremity pain with central spinal stenosis after failure of conservatie management and fluoroscopically directed epidural injections.
doi:10.7150/ijms.5303
PMCID: PMC3534877  PMID: 23289005
Central spinal stenosis; percutaneous adhesiolysis; steroids; local anesthetics; hypertonic sodium chloride solution
16.  A comparison of the analgesic efficacy of transforaminal methylprednisolone alone and with low doses of clonidine in lumbo-sacral radiculopathy 
Saudi Journal of Anaesthesia  2014;8(1):51-58.
Background:
Although transforaminal epidural steroid injections under fluoroscopic guidance have become a common mode of treatment of lumbosacral radiculopathy due to herniated disc, the efficacy of steroid with low doses of clonidine has not been compared yet.
Objectives:
Comparison of the analgesic efficacy of methylprednisolone alone and with low doses of clonidine for transforaminal injection in lumbosacral radiculopathy.
Study Design:
A randomized, double-blind trial.
Setting:
This study was performed at the Pain Clinic under the Department of Anaesthesiology, Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh, India.
Methods:
One hundred and eighty ASA grade I and II patients aged between 18 and 55 years were allocated into groups I, II and III to receive methylprednisolone 60 mg alone or methylprednisolone 60 mg with or without low doses of clonidine (0.5 mcg/kg or 1 mcg/kg) as transforaminal epidural injection. Pain relief and patient's satisfaction were evaluated with the global pain scale. Follow-up visits were advised at 1, 2, 4, 6 and 12 weeks and then at 6 months after injection. Associated complications were recorded.
Results:
Maximum pain relief was observed at 2 weeks after injection in all the three groups, with no difference in complication rate among the three groups. The most common complication observed was paresthesia in the nerve distribution. Greater than 60% improvement in pain scores was seen in 40% of the patients in group I, 50% of the patients in group II and 75% of the patients in group III.
Limitations:
This study is limited by the lack of a placebo group.
Conclusion:
Adding 1 mcg/kg clonidine to 60 mg methylprednisolone in transforaminal epidural injections provided better pain relief than 60 mg methylprednisolone with 0.5 mcg/kg clonidine or 60 mg methylprednisolone alone in patients suffering from lumbosacral radiculopathy, with practically no significant side-effects.
doi:10.4103/1658-354X.125937
PMCID: PMC3950453  PMID: 24665240
Epidural; lumbosacral radiculopathy; sciatica; transforaminal
17.  A prospective randomized, double-blind, controlled clinical trial comparing epidural butorphanol plus corticosteroid with corticosteroid alone for sciatica due to herniated nucleus pulposus 
Objective:
To compare the efficacy of up to 3 epidural butorphanol plus corticosteroid with corticosteroid alone for sciatica due to herniated nucleus pulposus.
Materials and Methods:
In a randomized, double-blind controlled clinical trial, we administered up to 3 epidural injections of either 80 mg (2 mL) of methylprednisolone acetate and 1 mg (1 mL) of butorphanol diluted with 7 mL of isotonic saline or 80 mg (2 mL) of methylprednisolone acetate diluted with 8 mL of isotonic saline by a lumbar interlaminar approach under fluoroscopic guidance to 120 patients (60 patients in each group) with sciatica due to a herniated nucleus pulposus lasting for 4 weeks to 1 year. All patients had scores higher than 30 mm on visual analog scale (VAS). Information on the use of paracetamol, intensity of pain on a VAS ranging from 0 (no pain) to 100 mm (worst pain possible), Schober's test (cm), Straight Leg Raising test, neurologic examination assessing sensory deficits, motor deficits and reflex changes, and Oswestry Low Back Pain Disability Questionnaire were evaluated at 3 weeks, 6 weeks, and 3 months after the first injection.
Results:
There were no significant differences between the 2 groups with regard to baseline characteristics, withdrawals, and complication rate. Three weeks, 6 weeks, and 3 months after the first injection, all the outcome measures in the butorphanol plus corticosteroid group were significantly different from that of the corticosteroid group.
Conclusions:
Epidural butorphanol plus corticosteroid injections, as compared with corticosteroid alone injections, offered marked improvement in pain, reflex, motor and sensory deficits, and functional status and reduced the need for analgesics.
Level of Evidence:
Therapeutic Level I.
doi:10.4103/2229-3485.92302
PMCID: PMC3275988  PMID: 22347697
Butorphanol; epidural; sciatica
18.  Contrast Spreading Patterns in Retrodiscal Transforaminal Epidural Steroid Injection 
Annals of Rehabilitation Medicine  2012;36(4):474-479.
Objective
To observe the contrast spreading patterns in the retrodiscal (RD) approach for transforaminal epidural steroid injections and their effect on pain reduction.
Method
Patients with L5 radiculopathy who were scheduled to receive lumbar TF-EPB were consecutively included. We randomly divided them into the L4-5 RD and L5-S1 RD groups and administered 1 cc of contrast dye into epidural space. We observed the shape and the location of contrast dye on the anterior-posterior and lateral views. We injected 1 cc of 0.5% lidocaine mixed with 20 mg of triamcinolone, and checked the pain intensity before and two weeks after the procedure by using visual analogue scale (VAS).
Results
In the L4-5 RD group (n=30), contrast spread over the L4 nerve root in 27 cases and the L4 and L5 nerve roots in 3 cases. In the L5-S1 RD group (n=33), contrast spread over the L5 nerve root in 20 cases, the S1 nerve root in 3 cases, and the L5 and the S1 nerve roots in 10 cases. The contrast spreading patterns could be divided into 4 patterns: the proximal root in 40 cases, the distal root in 19 cases, the anterior epidural space in 3 cases and an undefined pattern in 1 case.
Conclusion
In RD lumbar TF-EPB, the contrast dye mostly went into the cephalic root and about 60% spread over the proximal nerve root. There was less pain reduction when the contrast dye spread over the distal nerve root.
doi:10.5535/arm.2012.36.4.474
PMCID: PMC3438413  PMID: 22977772
Contrast dye; Epidural block; Retrodiscal; Transforaminal
19.  A Prospective, Observational Study of the Relationship Between Body Mass Index and Depth of the Epidural Space During Lumbar Transforaminal Epidural Steroid Injection 
Background and Objectives
Previous studies have concluded that transforaminal epidural steroid injections (ESIs) are more effective than interlaminar injections in the treatment of radiculopathies due to lumbar intervertebral disk herniation. There are no published studies examining the depth of epidural space using a transforaminal approach. We investigated the relationship between body mass index (BMI) and the depth of the epidural space during lumbar transforaminal ESIs.
Methods
Eighty-six consecutive patients undergoing lumbar transforaminal ESI at the L3-L4, L4-L5, and L5-S1 levels were studied. Using standard protocol, the foraminal epidural space was attained using fluoroscopic guidance. The measured distance from needle tip to skin was recorded (depth to foraminal epidural space). The differences in the needle depth and BMI were analyzed using regression analysis.
Results
Needle depth was positively associated with BMI (regression coefficient [RC], 1.13; P < 0.001). The median depths (in centimeters) to the epidural space were 6.3, 7.5, 8.4, 10.0, 10.4, and 12.2 for underweight, normal, preobese, obese I, obese II, and obese III classifications, respectively. Sex (RC, 1.3; P = 0.02) and race (RC, 0.8; P = 0.04) were also significantly associated with needle depth; however, neither factor remained significant when BMI was accounted as a covariate in the regression model. Age, intervertebral level treated, and oblique angle had no predictive value on foraminal depth (P > 0.2).
Conclusion
There is a positive association between BMI and transforaminal epidural depth, but not with age, sex, race, oblique angle, or intervertebral level.
doi:10.1097/AAP.0b013e31819a12ba
PMCID: PMC2715548  PMID: 19282707
20.  Postradiation lumbosacral radiculopathy with spinal root cavernomas mimicking carcinomatous meningitis 
Neuro-Oncology  2008;10(6):1035-1039.
Lumbosacral radiculopathy is a rare complication of radiotherapy and may be challenging to differentiate from diagnosis of a tumor recurrence. We reviewed the records of three patients with a past history of cancer and radiotherapy who were referred for suspicion of carcinomatous meningitis on lumbar MRI, but whose final diagnosis was radiation-induced lumbosacral radiculopathy. The three patients developed a progressive lumbosacral radiculopathy at 20, 13, and 47 years after lumbar radiotherapy delivered for renal cancer, Hodgkin’s disease, and a seminoma, respectively. MRI showed a diffuse, nodular enhancement of the cauda equina nerve roots on T1 sequences, suggestive of leptomeningeal metastasis. A slowly progressive clinical course over several years and negative cerebrospinal fluid cytologic analysis ruled out the diagnosis of carcinomatous meningitis. Because of the radiologic findings, a biopsy was performed in two patients. In the first, a biopsy limited to the arachnoid excluded a malignant infiltration. In the second, a biopsy of the enhancing lesions demonstrated spinal root cavernomas. These observations, together with three recent case reports in the literature, delineate a syndrome of “radiation-induced lumbosacral radiculopathy with multiple spinal root cavernomas” that mimics carcinomatous meningitis on MRI. Its diagnosis is important in order to avoid inappropriate treatment and useless or dangerous spinal root biopsies.
doi:10.1215/15228517-2008-069
PMCID: PMC2719001  PMID: 18755918
carcinomatous meningitis; cauda equina; cavernoma; radiotherapy
21.  Investigation of High-Sensitivity C-reactive Protein and Erythrocyte Sedimentation Rate in Low Back Pain Patients 
The Korean Journal of Pain  2010;23(2):147-150.
Background
Chronic low back pain can be a manifestation of lumbar degenerative disease, herniation of intervertebral discs, arthritis, or lumbar stenosis. When nerve roots are compromised, low back pain, with or without lower extremity involvement, may occur. Local inflammatory processes play an important role in patients with acute lumbosciatic pain. The purpose of this study was to assess the value of erythrocyte sedimentation rate (ESR) and high sensitivity C-reactive protein (hsCRP) measurements in patients with chronic low back pain or radiculopathy.
Methods
ESR and hsCRP were measured in 273 blood samples from male and female subjects with low back pain and/or radiculopathy due to herniated lumbar disc, spinal stenosis, facet syndrome, and other diseases. The hsCRP and ESR were measured prior to lumbar epidural steroid injection.
Results
The mean ESR was 18.8 mm/h and mean hsCRP was 1.1 mg/L. ESR had a correlation with age.
Conclusions
A significant systemic inflammatory reaction did not appear to arise in patients with chronic low back pain.
doi:10.3344/kjp.2010.23.2.147
PMCID: PMC2886244  PMID: 20556218
ESR; hsCRP; low back pain
22.  Assessing the effectiveness of ‘pulse radiofrequency treatment of dorsal root ganglion’ in patients with chronic lumbar radicular pain: study protocol for a randomized control trial 
Trials  2012;13:52.
Background
Chronic lumbar radicular pain can be described as neuropathic pain along the distribution of a particular nerve root. The dorsal root ganglion has been implicated in its pathogenesis by giving rise to abnormal impulse generation as a result of irritation, direct compression and sensitization. Chronic lumbar radicular pain is commonly treated with medications, physiotherapy and epidural steroid injections. Epidural steroid injections are associated with several common and rarer side effects such as spinal cord infarction and death. It is essential and advantageous to look for alternate interventions which could be effective with fewer side effects.
Pulse radio frequency is a relatively new technique and is less destructive then conventional radiofrequency. Safety and effectiveness of pulse radio frequency in neuropathic pain has been demonstrated in animal and humans studies. Although its effects on dorsal root ganglion have been studied in animals there is only one randomized control trial in literature demonstrating its effectiveness in cervical radicular pain and none in lumbar radicular pain. Our primary objective is to study the feasibility of a larger trial in terms of recruitment and methodology. Secondary objectives are to compare the treatment effects and side effects.
Methods/designs
This is a single-center, parallel, placebo-controlled, triple-blinded (patients, care-givers, and outcome assessors), randomized control trial. Participants will have a history of chronic lumbar radicular pain for at least 4 months in duration. Once randomized, all patients will have an intervention involving fluoroscopy guided needle placement to appropriate dorsal root ganglion. After test stimulation in both groups; the study group will have a pulse radio frequency treatment at 42°C for 120 s to the dorsal root ganglion, with the control group having only low intensity test stimulation for the same duration. Primary outcome is to recruit at least four patients every month with 80% of eligible patients being recruited. Secondary outcomes would be to assess success of intervention through change in the visual analogue scale measured at 4 weeks post intervention and side effects. Allocation to each group will be a 1:1 ratio with allocation block sizes of 2, 4, and 6.
Trial registration
ClinicalTrials.gov NCT01117870
doi:10.1186/1745-6215-13-52
PMCID: PMC3404908  PMID: 22540851
Lumbar radicular pain; Pulse radio frequency; Dorsal root ganglion; Radiofrequency of DRG
23.  Epidural steroid injections in the management of low-back pain with radiculopathy: an update of their efficacy and safety 
European Spine Journal  2011;21(2):204-213.
Introduction
Epidural steroid injections (ESIs) have been widely used for over 50 years in the treatment of low-back pain with radiculopathy. Most interventional pain physicians strongly believe in their efficacy and safety. Recent Cochrane systematic reviews have disclosed controversial results and have questioned the effectiveness of ESIs. Moreover, a few neurological adverse events have been reported recently.
Methods
A literature search of systematic reviews analysing the effectiveness and complications of ESIs was carried out. The scientific quality of the reviews was assessed using the validated index of Oxman and Guyatt. We relied on data abstraction and quality ratings of the placebo-controlled trials as reported by high-quality systematic reviews.
Results
Two types of systematic reviews were found. The Cochrane high-quality systematic reviews combining the three approaches and different pathologies were predominantly non-conclusive. The second type of review, emanating from the US Evidence-based Practice Centers, distinguishing between the routes of administration and between the principal pathologies found a moderate short-term benefit of ESIs versus placebo in patients with disc herniation and radiculitis, in keeping with the clinical experience. ESIs are generally well tolerated and most complications are related to technical problems. Cases of paraplegia, complicating the foraminal route and related to the violation of a radiculomedullary artery, have been recently reported. They are predominantly observed in previously operated patients.
Conclusions
Epidural steroid injections have a moderate short-term effect in the management of low-back pain with radiculopathy. Severe neurological complications are exceptional, but call for research for alternative approaches to the foramen as well as for means to detect an eventual arterial injury.
doi:10.1007/s00586-011-2007-z
PMCID: PMC3265586  PMID: 21922288
Epidural; Steroid injection; Radiculopathy; Discal herniation; Radiculitis; Lumbar canal stenosis
24.  Effects of epidural lidocaine anesthesia on bulls during electroejaculation. 
The Canadian Veterinary Journal  2001;42(2):116-120.
Two experiments were conducted to determine whether caudal epidural lidocaine anesthesia reduces a stress response to electroejaculation. In the 1st experiment, changes in cortisol and progesterone concentrations in serial blood samples were used to assess the stress response to restraint (control), transrectal massage, caudal epidural injection of saline, electroejaculation after caudal epidural injection of lidocaine, and electroejaculation without epidural lidocaine. In the 2nd experiment, behavioral responses were subjectively scored in bulls that were electroejaculated with or without caudal epidural lidocaine anesthesia. Cortisol and progesterone concentrations were significantly elevated after electroejaculation, whether or not bulls received caudal epidural anesthesia. Elevations in cortisol and progesterone were lower and fewer bulls vocalized during electroejaculation when given caudal epidural anesthesia; however, the differences were not significant.
PMCID: PMC1476483  PMID: 11272454
25.  Higher risk of dural tears and recurrent herniation with lumbar micro-endoscopic discectomy 
European Spine Journal  2010;19(3):443-450.
Existing studies on micro-endoscopic lumbar discectomy report similar outcomes to those of open and microdiscectomy and conflicting results on complications. We designed a randomised controlled trial to investigate the hypothesis of different outcomes and complications obtainable with the three techniques. 240 patients aged 18–65 years affected by posterior lumbar disc herniation and symptoms lasting over 6 weeks of conservative management were randomised to micro-endoscopic (group 1), micro (group 2) or open (group 3) discectomy. Exclusion criteria were less than 6 weeks of pain duration, cauda equina compromise, foraminal or extra-foraminal herniations, spinal stenosis, malignancy, previous spinal surgery, spinal deformity, concurrent infection and rheumatic disease. Surgery and follow-up were made at a single Institution. A biomedical researcher independently collected and reviewed the data. ODI, back and leg VAS and SF-36 were the outcome measures used preoperatively, postoperatively and at 6-, 12- and 24-month follow-up. 212/240 (91%) patients completed the 24-month follow-up period. VAS back and leg, ODI and SF36 scores showed clinically and statistically significant improvements within groups without significant difference among groups throughout follow-up. Dural tears, root injuries and recurrent herniations were significantly more common in group 1. Wound infections were similar in group 2 and 3, but did not affect patients in group 1. Overall costs were significantly higher in group 1 and lower in group 3. In conclusion, outcome measures are equivalent 2 years following lumbar discectomy with micro-endoscopy, microscopy or open technique, but severe complications are more likely and costs higher with micro-endoscopy.
doi:10.1007/s00586-010-1290-4
PMCID: PMC2899770  PMID: 20127495
Lumbar disc herniation; Discectomy; Microdiscectomy; Micro-endoscopic discectomy

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